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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-000176-35 | EudraCT Number |
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The clinical study using a sub-therapeutic dose of a GnRH antagonist to reduce overactive LH pulsatility in women with PCOS. With the intervention and lowered LH action we anticipate to decrease androgen levels in women with PCOS. The aim to show for the first time that low-dose GnRH-antagonists can lower LH pulsatility by 20-30% and decrease androgen levels without blunting the hypothalamic-pituitary-gonadal axis and thereby the reproductive functions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.0625 mg | Experimental | Test the efficacy of Ganirelix administered subcutaneously at single-dose regimen of 0.0625 mg in 10 women with PCOS, in rectifying LH pulse frequency and LH amplitude |
|
| 0.025 mg | Experimental | Test the efficacy of Ganirelix administered subcutaneously at single-dose regimen of 0.025 mg in 10 women with PCOS, in rectifying LH pulse frequency and LH amplitude. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ganirelix | Drug | An intra-venous cannula will be inserted and blood will be sampled at 10-min intervals for a 4-h baseline period commencing at 0800 h. Ganirelix will be then administered subcutaneously at single-dose regimen at 0.0625 mg (n = 10 women with PCOS). After Ganirelix administration sampling will continue at 10-min intervals for 4 h. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum LH level | The degree of gonadotropin suppression will be determined by calculating the percent inhibition from the pre-antagonist period [(mean PRE - nadir)/mean PRE] x 100, where nadir hormone levels will be calculated using a moving average. | every 10 minutes for 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Variation in LH secretion amplitude before and after Ganirelix* injection (area under the curve) | at the beginning and at the end of the 8 hours | |
| Variation in androgen production | defined by the difference between the measurement at H8 and the measurement at H0 (4 hours before injection) of total testosterone and androstenedione. |
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Inclusion Criteria:
Exclusion Criteria:
Patients followed in endocrine gynecology consultation in the Jeanne de Flandre department
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| Name | Affiliation | Role |
|---|---|---|
| Sophie Catteau-Jonard, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Jeanne de Flandre | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| C061018 | ganirelix |
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|
| Ganirelix | Drug | An intra-venous cannula will be inserted and blood will be sampled at 10-min intervals for a 4-h baseline period commencing at 0800 h. Ganirelix will be then administered subcutaneously at single-dose regimen at 0.025 mg (n = 10 women with PCOS). After Ganirelix administration sampling will continue at 10-min intervals for 4 h. |
|
| at 4 hours after injection |
| change in FSH levels | defined as the difference between the measurement at H8 and the measurement at H0 (4 hours prior to injection) of FSH | at 4 hours post-injection |
| change in estradiol levels | defined as the difference between the measurement at H8 and the measurement at H0 (4 hours prior to injection) of estradiol | at 4 hours post-injection |
| change in AMH levels | defined as the difference between the measurement at H8 and the measurement at H0 (4 hours prior to injection) of AMH. | at 4 hours post-injection |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |